The US Food and Drug Administration announced the creation of a new drug on Wednesday Digital Health Advisory Committeewhich “brings together experts from across the field who can help ensure our regulation of these exciting tools maintains an appropriate pace while working within safety and effectiveness standards,” said Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence .
WHY IT’S IMPORTANT
“Technology is advancing at an incredible pace,” he said, and the committee will help the FDA keep a clear eye on the rapidly changing scientific and technical issues surrounding digital health tools and technologies – not least rapidly developing areas such as artificial intelligence and machine learning. Augmented and virtual reality, digital therapeutics, wearables, remote patient monitoring and more.
The Group – the newest addition to The FDA’s other advisory committeesIt is planned to be fully operational in 2024. It will be tasked with advising FDA leaders on a range of digital health needs while providing expertise and perspectives to improve the agency’s understanding of the “benefits, risks, and clinical outcomes” of various emerging technologies.
As the FDA works to ensure the safety and effectiveness of new digital health tools – not only those mentioned above, but also in other areas such as decentralized trials, patient-generated health data, and cybersecurity – the FDA also recognizes the need not to stifle innovation.
Therefore, the agency will seek the opinion of the committee, which will consist of nine voting members including the chair, adding other experts depending on the topic. It will include people with technical and scientific expertise from different disciplines and backgrounds to better help ensure that digital health devices are designed and targeted to meet the needs of diverse populations.
The FDA says anyone interested in mentoring or nominating a representative should submit their nominations electronically through the advisory committee members Nomination portal.
THE BIGGER TREND
The agency has had its hands full in recent years dealing with a variety of regulatory challenges related to a wide range of digital health technologies.
Most recently, the focus has been on AI-enabled medical devices and a new one final guidelines for its Breakthrough Devices program. (It also keeps a close eye on the Medical device supply chain.)
But the FDA has also been busy with clinical decision support software, genomic data and more.
In recent years, the agency has promised a more open approach to AI and machine learning. We provided an in-depth look at how the agency is evolving its regulatory approach to keep pace with healthcare innovations.
ON THE RECORD
“Many of these technologies are new and tend to change quickly,” Tazbaz said. “It is our duty to gain as much knowledge about this as possible while establishing and implementing appropriate regulations to promote innovation while protecting public health.”
“As one of our strategic priorities, our goal is to advance health equity by expanding access by providing prevention, wellness and healthcare to all people where they live – at home, at work, in metropolitan areas and in rural communities Provide health care,” added Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
“Digital health technologies are critical to achieving this transformation in healthcare. As digital health technologies evolve, the FDA must leverage knowledge within and outside the agency to ensure we are appropriately applying our regulatory authority to protect patient health and continue to support innovation.”
Mike Miliard is Editor-in-Chief of Healthcare IT News
Email the author: mike.miliard@himssmedia.com
Healthcare IT News is a HIMSS publication.